NCT03666091|CompletedDMC
Study and Monitoring of Early Undifferentiated Arthritis
ESPOIR
Etude et Suivi Des POlyarthrites Indifférenciées Récentes
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ESPOIR
Etude et Suivi Des POlyarthrites Indifférenciées Récentes
Sponsor study identifier
observational
813
0 countries
N/A
Study Start
November 13, 2002
Actual (reported)Primary Completion
April 19, 2005
Actual (reported)Study Completion
July 13, 2025
Actual (reported)The French Society of Rheumatology initiated a large national multicenter, longitudinal and prospective cohort, ESPOIR, in order to set up databases to allow various investigations on diagnosis, prognostic markers, epidemiology, pathogenesis and medico-economic factors in the field of early arthritis and rheumatoid arthritis. The primary objective is to set-up a multicentre cohort of early arthritis (less than 6 months) in France that could serve as a database to studies of various natures. Specific objectives are in the following domains:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 13, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 13, 2002
Actual (reported)April 19, 2005
Actual (reported)August 31, 2018
Actual (reported)September 11, 2018
Actual (reported)July 13, 2025
Actual (reported)Remaining in the cohort.
Presence of the patient at the visit.
20 years
Prescription of synthetic or biologic disease-modifying antirheumatic drugs (DMARD).
Number of patients treated or not.
20 years
Patient disability evaluation.
Evaluation by Health Assessment Questionnaire Disability Index (HAQ-DI). The following categories are assessed by the HAQ-DI: dressing and grooming, arising, eating, walking, hygiene, reach, grip, common daily activities. The patients report the amount of difficulty they have in performing some of these activities. Each question asks on a scale ranging from 0 to 3. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.
20 years
Change in Disease Activity (levels of activity or remission)
1. Disease Activity Score (DAS28). The DAS28 provides an absolute indication of RA disease activity on a scale of 0.49 to 9.07 A DAS28 value \>5.1 corresponds to a high disease activity, A DAS28 value between 3.2 and 5.1 corresponds to a moderate disease activity, A DAS28 value between 2.6 and 3.2 corresponds to a low disease activity, A DAS28 value \< 2.6 corresponds to remission. 2. Physician and patient activity VAS. Scales from 0 to 100. A high value indicates extreme activity.
20 years
A total of 814 patients with early arthritis were included be- tween November 2002 and april 2005.One patient removed his consent form. All the centres were active and each regional centre recruited between 35 and 83 patients.
Garnero P, Falkenlove Madsen S, Eymard F, Sellam J, Chapurlat R, Bay-Jensen AC. Serum biochemical marker of synovial tissue turnover, C1M, predicts radiological progression in early rheumatoid arthritis. RMD Open. 2025 Jul 10;11(3):e005501. doi: 10.1136/rmdopen-2025-005501.
Vittecoq O, Guillou C, Hardouin J, Gerard B, Berenbaum F, Constantin A, Rincheval N, Combe B, Lequerre T, Cosette P. Validation in the ESPOIR cohort of vitamin K-dependent protein S (PROS) as a potential biomarker capable of predicting response to the methotrexate/etanercept combination. Arthritis Res Ther. 2022 Mar 21;24(1):72. doi: 10.1186/s13075-022-02762-5.
Serum at baseline, 6, 12, 18, 24, 36, 60, 120, 180 and 240 months / Urine at baseline, 24 and 36 months / DNA
Bernard COMBE, MD, PHD
Montpellier University Hospital rheumatology department
813 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2018
First Posted
September 11, 2018
Study Start
November 13, 2002
Actual (reported)Quality of life assessed by EQ-5D-3L/ EUROQOL
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The EQ VAS records the respondent's self-rated health (0-100).
20 years
Quality of life assessed by MOS-SF-36/ MOS 36-Item Short-Form Health Survey
MOS-SF-36/ MOS 36-Item Short-Form Health Survey contains 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides the perceived change in health. Each dimension has a scale (0-100). Low score=poor quality of life.
15 years (from baseline to 15 years)
Quality of life assessed by AIMS2-SF/Arthritis Impact Measurement Scales 2 Short Form
AIMS2-SF/Arthritis Impact Measurement Scales 2 Short Form contains 26 items : upper-extremity functioning, lower-extremity functioning, affect, symptoms, social interaction, and role. Scores are summed and converted to a range of 0-10. Higher scores=poorer health.
14 years (from baseline to 14 years)
Radiographic damage evaluation
Structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components.The SHS method evaluates, in each hand, 16 areas for erosions and 15 areas for JSN, and, in each foot, 6 areas for erosions and 6 areas for JSN. The erosion score per hand joint can range from 0 to 5. JSN and joint subluxation or luxation are combined in a single score, from 0 to 4. The maximal score for erosion and JSN are 160 and 120, respectively, for the hands and 120 and 48, respectively, for the feet. The maximal total SHS is 448.
20 years
Contact the study team to confirm eligibility.
Kumaradev S, Roux C, Sellam J, Perrot S, Pham T, Dugravot A, Molto A. Socio-demographic determinants in the evolution of pain in inflammatory rheumatic diseases: results from ESPOIR and DESIR cohorts. Rheumatology (Oxford). 2022 Apr 11;61(4):1496-1509. doi: 10.1093/rheumatology/keab562.
Roubille C, Coffy A, Rincheval N, Dougados M, Flipo RM, Daures JP, Combe B. Ten-year analysis of the risk of severe outcomes related to low-dose glucocorticoids in early rheumatoid arthritis. Rheumatology (Oxford). 2021 Aug 2;60(8):3738-3746. doi: 10.1093/rheumatology/keaa850.
Valdeyron C, Soubrier M, Pereira B, Constantin A, Morel J, Gaudin P, Combe B, Gremeau AS, Dejou-Bouillet L, Pouly JL, Sapin V, Oris C, Brugnon F. Impact of disease activity and treatments on ovarian reserve in patients with rheumatoid arthritis in the ESPOIR cohort. Rheumatology (Oxford). 2021 Apr 6;60(4):1863-1870. doi: 10.1093/rheumatology/keaa535.
Mouterde G, Gamon E, Rincheval N, Lukas C, Seror R, Berenbaum F, Dupuy AM, Daien C, Daures JP, Combe B. Association Between Vitamin D Deficiency and Disease Activity, Disability, and Radiographic Progression in Early Rheumatoid Arthritis: The ESPOIR Cohort. J Rheumatol. 2020 Nov 1;47(11):1624-1628. doi: 10.3899/jrheum.190795. Epub 2019 Dec 15.
Lukas C, Mary J, Debandt M, Daien C, Morel J, Cantagrel A, Fautrel B, Combe B. Predictors of good response to conventional synthetic DMARDs in early seronegative rheumatoid arthritis: data from the ESPOIR cohort. Arthritis Res Ther. 2019 Nov 15;21(1):243. doi: 10.1186/s13075-019-2020-x.
Primary Completion
April 19, 2005
Actual (reported)Study Completion
July 13, 2025
Actual (reported)Last Updated
August 26, 2025
Record last verified: 2025-07
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